Humanitarian Use Device
A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals per year in the United States.
Under 21 CFR 814.124, Institutional Review Boards (IRBs) are required to approve the use of a Humanitarian Use Device (HUD), except in emergency situations, for an institution to deliver the device to patients. In addition to the initial approval, IRBs must perform continuing review of a HUD application at least yearly
Note: These forms are best downloaded using Internet Explorer (IE) as your web browser but then click "Save" because they are best opened in Microsoft Word from after being saved to your computer (Click the picture for an example). If you are experiencing problems downloading a form from our page, and using an alternate browser has not helped (i.e., Netscape Navigator, Internet Explorer), please call the Office of the IRB at 210-567-2351.
Instructions:
Always return to this webpage to create new submissions to ensure you are using the most current forms.
Form A Instructions |
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Form B-2 Instructions |
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General Information sheet |
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| Description of Use of the HUD | |
Use of Investigational Device Form (including Humanitarian Use Device) |
Form P Instructions |
Use of Non-Exempt Investigational Device Form (No IDE) (including Humanitarian Use Device) |
Form P-1 Instructions |
Copy of package insert or FDA approved label (PDR reference) |
Include for drug or device studies using the FDA approved medication/device for approved medical indication. |
Humanitarian Use Device - Report of Emergency Use (HUD used without IRB approval) |
Only used when an HUD is used in an Emergency without prior IRB approval or by a physician not already approved to use the HUD (in a location not approved) Instructions[HTML] |